Elixaban Tablet 2.5 mg (Apixaban)

Adult dose

This medicine should be taken with water, with or without food. If a patient forgets to take a dose, they should take this medicine as soon as possible and continue taking it twice daily as before. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery The recommended dose is 2.5 mg of this medicine taken orally twice daily. The initial dose should be taken 12 ~ 24 hours after surgery. The recommended duration of treatment for patients who have undergone hip replacement surgery is 32 ~ 38 days. The recommended duration of treatment for patients who have undergone knee replacement surgery is 10 ~ 14 days. 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose is 5 mg of this medicine taken orally twice daily. However, for patients with nonvalvular atrial fibrillation who have at least 2 of the following characteristics, the recommended dose is 2.5 mg of this medicine taken orally twice daily; age ≥80 years, body weight ≤60kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Treatment should be continued long term. There is limited experience with administering the recommended dose of this medicine together with antiplatelet agents after hemostasis has been achieved in patients with nonvalvular atrial fibrillation and acute coronary syndrome and/or undergoing percutaneous coronary intervention. (See “5. General precautions, 1) Interactions with other drugs that affect hemostasis” under Precautions for Use and “12. Clinical Trial Information, 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, AUGUSTUS trial.”) 3) Treatment of deep vein thrombosis and pulmonary embolism The recommended dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 10mg taken orally twice daily for 7 days, followed by 5mg taken orally twice daily. 4) Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended dose is 2.5mg of this medicine taken orally twice daily, and it should be administered after completion of at least 6 months of treatment with this medicine or another anticoagulant. 2. Switching medications When switching from parenteral anticoagulant treatment to this medicine or from this medicine to a parenteral anticoagulant, the switch can be made at the time of the next scheduled dose. 1) Switching from vitamin K antagonist treatment to this medicine To switch from vitamin K antagonist treatment to this medicine, discontinue warfarin or another vitamin K antagonist and start this medicine when the International Normalized Ratio (INR) is less than 2.0. 2) Switching from this medicine to vitamin K antagonist treatment To switch from this medicine to vitamin K antagonist treatment, continue taking this medicine for 2 days after starting the vitamin K antagonist. After 2 days of concomitant treatment with this medicine and a vitamin K antagonist, measure the INR immediately before the scheduled dose of this medicine, and continue concomitant treatment with this medicine and the vitamin K antagonist until the INR is 2.0 or higher. 3. Renal impairment As there is no clinical experience in patients on dialysis or in patients with creatinine clearance less than 15 mL/min, use of this medicine is not recommended. 1) Prevention of venous thromboembolism in adult patients who have undergone hip or knee replacement surgery No dose adjustment is necessary in patients with mild or moderate renal impairment. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased in these patient groups; therefore, this medicine should be administered with caution in these patients. 2) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation No dose adjustment is necessary in patients with mild or moderate renal impairment. However, patients with serum creatinine ≥1.5 mg/dL (133 micromole/L) who are aged ≥ 80 years or weigh ≤ 60kg should receive 2.5 mg of this medicine twice daily. Patients with severe renal impairment (creatinine clearance 15-29 mL/min) should receive 2.5 mg of this medicine twice daily, regardless of age or body weight. 3) Treatment of deep vein thrombosis and pulmonary embolism/ Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism No dose adjustment is necessary in patients with mild or moderate renal impairment. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased in these patient groups; therefore, this medicine should be administered with caution in these patients. 4. Hepatic impairment This medicine should not be administered to patients with liver disease associated with coagulopathy and a clinically significant risk of bleeding. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child Pugh A or B), but this medicine should be administered with caution. Use of this medicine is not recommended in patients with severe hepatic impairment. Patients with hepatic ALT/AST levels exceeding 2 times the upper limit of normal or total bilirubin levels 1.5 times or more the upper limit of normal were excluded from clinical trials; therefore, this medicine should be administered to such patients with caution. Liver function tests should be performed before starting treatment with this medicine. 5. Patients unable to swallow tablets For patients unable to swallow tablets, this medicine may be crushed immediately before use and mixed with water or a beverage such as applesauce for oral administration. This medicine may also be crushed, mixed with 60mL of water, and administered through a nasogastric tube.

This medication is used to prevent or treat thrombus formation by inhibiting excessive blood clotting. While taking this medication, there is a risk of bleeding, so signs of bleeding should be monitored closely. If severe bleeding occurs, the use of this medication should be stopped immediately, and the healthcare provider should be consulted. Regular monitoring of drug levels is not required with specific blood tests, but blood concentration measurement may be helpful in emergencies. Patients who have an allergy to this medication, active bleeding, severely impaired liver function, or a recent history of intracranial hemorrhage or gastrointestinal ulcers should not take this medication. Taking it concurrently with other anticoagulants may also pose risks, so it is essential to inform the healthcare provider of all medications currently being taken. Patients with renal or liver impairment should be cautious when using this medication, and taking this medication with certain psychiatric medications or non-steroidal anti-inflammatory drugs may increase the risk of bleeding. Special care is required for elderly or underweight patients, as their bleeding risk may be further increased. Patients receiving spinal or epidural anesthesia may be at risk of serious neurological injury due to the use of this medication, so it should be discussed with the healthcare provider. In cancer patients, the risks and benefits of using this medication for the prevention or treatment of thrombi should be carefully evaluated. Generally, abnormalities such as bleeding, bruising, or nosebleeds may occur when taking this medication, so any unusual symptoms should be reported to a healthcare provider immediately. Additionally, if a surgical or invasive procedure is planned, this medication should be discontinued at least 24 to 48 hours prior, and resumption should be considered based on the bleeding risk and condition after the procedure. Temporarily discontinuing this medication may increase the risk of thrombus formation, so it should be resumed as soon as possible. Use of this medication is not recommended during pregnancy or breastfeeding, and safety in pediatric patients has not been established. Due to numerous drug interactions, it is crucial to discuss any other medications being taken with a healthcare provider. In case of overdose, the risk of bleeding may significantly increase, so the prescribed dose must be strictly followed; since there is no antidote, if bleeding occurs, immediate medical attention is necessary.

• Hemorrhage
• contusion
• nosebleed
• hematoma
• anemia
• thrombocytopenia
• hypersensitivity
• allergic edema
• anaphylactic reaction
• cerebral hemorrhage

This medication should be stored in a sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature in the range of 1 to 30 degrees Celsius.

Appearance

Pale yellow, round, film-coated tablet

Package unit

60 tablets/PTP [(10 tablets/PTP x 6)]